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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mouthguard, prescription
510(k) Number K030832
Device Name PRIMOSPLINT SYSTEM
Applicant
COSMEDENT, INC.
401 NORTH MICHIGAN AVE.
SUITE 2500
CHICAGO,  IL  60611
Applicant Contact MICHAEL O'MALLEY
Correspondent
COSMEDENT, INC.
401 NORTH MICHIGAN AVE.
SUITE 2500
CHICAGO,  IL  60611
Correspondent Contact MICHAEL O'MALLEY
Classification Product Code
MQC  
Date Received03/17/2003
Decision Date 09/17/2003
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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